Citizen petitions
This article was originally published in The Tan Sheet
Executive Summary
More than 40 citizen petitions and petitions for stay or reconsideration relating to OTCs, supplements and functional foods filed with FDA between Jan. 1, 2000 and March 2, 2001. Among issues raised, FDA agrees in recent letter with C.B. Fleet's request that bisacodyl, in enema dosage form and as part of bowel cleansing kits, be included in OTC laxative final monograph. Agency previously had concluded data support ingredient's classification as Category I (1"The Tan Sheet" March 13, 2000, p. 16). Pending petition filed by Braintree Labs in August seeks reclassification of sodium phosphate bowel preparations to Rx-only status. In April 6 petition, Lachman Consultant Services requests ANDA suitability determination for nizatidine 75 mg capsules. The listed drug, Whitehall-Robins' Axid AR, comes in tablet form. Absent a pediatric extension, Whitehall loses exclusivity April 1
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In Brief
Combe sells most of its OTC brands